ADIposity and Bone Metabolism: Effects of eXercise-induced Weight Loss in Obese Adolescents
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- change from baseline fat mass measured by Dual energy X-ray Absorptiometry (DXA)
研究概览
简要总结
The present protocol is mainly involved in the understanding of the local interaction between the released products by fat tissue and hormones production of bone tissue. These complex interactions between adipocyte and osteocyte activities could explain the mechanisms of the body responses to the strategies of weight loss that include diet and/or physical activity program, as well as the side effects encountered by these interventions.
Adolescence is a period of development characterized by many metabolic and somatic changes that may influence weight. Weights bearing physical activities are a key factor allowing body composition changes (i.e. fat and bone tissue). The difficulties of managing weight and the onset of overweight and obesity during this very important growth spurt lead to various hormonal dysregulation. The specific mechanisms of the evolution and interactions between these two parameters (fat and bone tissue) are not yet elucidated; therefore our aim is to analyze the possible connections between fat tissue and the quality of the skeleton in order to reduce related risks of the consequence of weight loss in obese individuals.
详细描述
The complex consequences of childhood obesity represent major concerns in most developed countries, largely contributing to metabolic complications with costly repercussions for the burden of disease. The burden is exemplified by high prevalence rates of overweight or obesity.
The ADIBOX protocol was designed to provide a better understanding of the bone-adipocyte cross-talk in adolescents with obesity and the effects of physical activity-induced weight loss on this cross-talk.
Obesity effectively leads to hormonal alterations favoring the accumulation of fat mass and loss of bone mass. Advancing the knowledge of the complex interactions between adipocyte and osteocyte activities may contribute to the mechanistic understanding of the body's responses to weight loss during adolescence and prevent cardiovascular risk. Indeed, the adipose-bone tissue cross-talk has been recently linked with cardiovascular diseases. Similarly as adipose tissue, released-products from bone tissue may act directly or indirectly on cardiovascular risk and diseases.
The ADIBOX study, a 40 weeks longitudinal study (LS) with repeated measures on four occasions (baseline and every fourteen weeks), will allow us to understand the effects of physical activity-induced weight loss on this cross-talk in obese adolescents.
Data will be analyzed using Stata (StataCorp, College Station, USA) and IBM Statistics SPSS version 22 (IBM Corp, 2013, Chicago, IL, USA) and significance will be accepted at a two-sided alpha level of p<0.05. After testing for normal distribution (Shapiro-Wilk test), data will be treated either by parametric or non-parametric analyses according to statistical assumptions.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 盲法
- None
入排标准
- 年龄范围
- 12 Years 至 16 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All adolescent girls will have to be free of any recent history of hospitalization (past two years) or of systemic illness lasting more than two weeks in the past 12 months. .
排除标准
- •pregnant girl
- •insulin-resistance
- •hypo or hyper-thyroid
- •consuming alcohol
结局指标
主要结局
change from baseline fat mass measured by Dual energy X-ray Absorptiometry (DXA)
时间窗: at 10 months.
change from baseline bone mass measured by Dual energy X-ray Absorptiometry (DXA)
时间窗: at 10 months
次要结局
- Metabolomics analysis in blood plasma(at 10 months)
- Ex-vivo mechanistic analysis(at 10 months)
- Adolescents' observance to the weight loss lifestyle program(at 10 months)
- posterior wall thickness measured by echocardiography(at 10 months)
- valves velocity measured by echocardiography(at 10 months)
- Tanner's stages model for pubertal maturation(at 10 months.)
- bone mineral density measured by Peripheral Quantitative Computed Tomography(at 10 months.)
- weight waist(at 10 months.)
- lower limb bone lengths(at 10 months.)
- bone mineral status measured by Quantitative Ultra-Sound (QUS) on the non-dominant calcaneus.(at 10 months.)
- left ventricular end systolic diameter measured by echocardiography(at 10 months)
- interventricular septum thickness measured by echocardiography(at 10 months)
- left ventricular ejection fraction measured by echocardiography(at 10 months)
- carotid-intima-media thickness measured by echography(at 10 months)
- Endocrine assays(at 10 months.)
- Physical activity measured with International Physical Activity Questionnaire(at 10 months.)
- isovolumic relaxation time measured by echocardiography(at 10 months)
- strain rate measured by echocardiography(at 10 months)
- waist circumference(at 10 months.)
- Energy metabolism assessed by cycle-ergometer submaximal aerobic fitness(at 10 months.)
- Whole body measured by Dual energy X-ray Absorptiometry (DXA)(at 10 months)
- left ventricular end diastolic diameter measured by echocardiography(at 10 months)
- left ventricular mass indexed measured by echocardiography(at 10 months)
- myocardial dyssynchrony measured by echocardiography(at 10 months)